As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower...more
9/24/2021
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Insurance ,
Healthcare Reform ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Proposed Legislation ,
Regulatory Agenda
On August 10, 2021, the Senate passed H.R. 3684, a roughly $1 trillion infrastructure bill (the “Infrastructure Bill”) that authorizes funds for federal-aid highways, transit, broadband access and other infrastructure...more
The Biden Administration’s American Rescue Plan Act of 2021 (H.R. 1319) (the “Act”) could present an opportunity for the growth of utilization of ambulatory surgery centers (“ASCs”), continuing the trend of migration of...more
On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more
12/3/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Discounts ,
Drug Pricing ,
Final Rules ,
Fixed-Fee ,
Medicaid ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors
As highlighted in a May 2020 Milbank Memorial Fund white paper titled, “How Payment Reform Could Enable Primary Care to Respond to COVID-19,” the COVID-19 public health emergency has driven transformation in the provision of...more
On June 24, 2020, House Democrats proposed the Patient Protection and Affordable Care Enhancement Act (H.R. 1425) (the “Proposed Act”), legislation aimed at reinforcing the Affordable Care Act (the “ACA”) by: (i) lowering...more
On March 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum to provide information to organizations that participate in the Programs of All-Inclusive Care for the Elderly (“PACE”) program in...more
On March 10, 2020, the Centers for Medicare & Medicaid Services (“CMS”) supplemented the guidance that we previously discussed in our March 6, 2020 blog post in order to provide additional guidance to healthcare providers,...more
On March 4, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced several measures aimed at preventing the spread of the Novel Coronavirus 2019 (“COVID-19”). Described by CMS Administrator Seema Verma as...more
Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”),...more
12/13/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Data Collection ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Information Requests ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs ,
Section 340B
On April 21, 2019, the Center for Medicare and Medicaid Innovation (“CMMI”) announced the CMS Primary Cares Initiative – a voluntary, risk-based initiative to transform the Medicare program’s reimbursement of primary care...more
12/2/2019
/ Alternative Payment Models (APM) ,
Applications ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Fee-for-Service ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Letters of Intent ,
Medicaid ,
Medicare ,
Physicians ,
Value-Based Care
The Centers for Medicare and Medicaid Services (“CMS”) healthcare audit programs – including the Unified Program Integrity Contractors (“UPICs”) audit program, the Recovery Audit Contractor (“RAC”) program, the Comprehensive...more
On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more
2/12/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
Federal Register ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors ,
Transparency ,
Trump Administration
On December 27, 2018, the U.S. District Court for the District of Columbia issued an opinion that ruled against the Trump Administration in its plan to cut funding from the 340B Drug Pricing Program (“340B...more
1/15/2019
/ American Hospital Association ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Medical Reimbursement ,
Medicare ,
Pharmaceutical Industry ,
Preliminary Injunctions ,
Prescription Drugs ,
Section 340B ,
Trump Administration
As discussed in our August 16, 2018 blog post, CMS Proposes Massive Changes to ACO Program – Pushing Providers to Accept Downside Risk, on August 9, 2018, the Centers for Medicare & Medicaid Services (“CMS”) published a...more